Systems and methods for peritoneal dialysis

ABSTRACT

Systems and methods relating to dialysis therapy, particularly continuous flow dialysis therapy, are provided. The present invention includes a single closed fluid path along which a minimal amount of therapy fluid including dialysate is fed into, continuously circulated and cleaned such that a therapeutic effective amount of solutes, excess water and the like can be removed from the patient connected to the closed fluid loop during treatment.

PRIORITY CLAIM

This application is a continuation of U.S. patent application Ser. No.10/623,317, filed Jul. 17, 2003, and also claims the benefit of U.S.Provisional Pat. Appl. No. 60/397,045, filed Jul. 19, 2002, bothentitled “Systems And Methods For Peritoneal Dialysis”; the entirecontents of both applications are hereby incorporated by reference andrelied upon.

BACKGROUND OF THE INVENTION

The present invention generally relates to systems and methods forproviding peritoneal dialysis. More specifically, the present inventionrelates to systems and methods for providing continuous flow peritonealdialysis.

Due to disease, insult or other causes, a person's renal system canfail. In renal failure of any cause, there are several physiologicalderangements. The balance of water, minerals and the excretion of dailymetabolic load is no longer possible in renal failure. During renalfailure, toxic end products of nitrogen metabolism (e.g., urea,creatinine, uric acid, and others) can accumulate in blood and tissues.

Kidney failure and reduced kidney function have been treated withdialysis. Dialysis removes waste, toxins and excess water from the bodythat would otherwise have been removed by normal functioning kidneys.Dialysis treatment for replacement of kidney functions is critical tomany people because the treatment is life saving. One who has failedkidneys could not continue to live without replacing at least thefiltration functions of the kidneys.

Hemodialysis and peritoneal dialysis are two types of dialysis therapiescommonly used to treat loss of kidney function. Hemodialysis treatmentremoves waste, toxins and excess water directly from the patient'sblood. The patient is connected to a hemodialysis machine and thepatient's blood is pumped through the machine. For example, needles orcatheters can be inserted into the patient's veins and arteries toconnect the blood flow to and from the hemodialysis machine. As bloodpasses through a dialyzer in the hemodialysis machine, the dialyzerremoves the waste, toxins and excess water from the patient's blood andreturns the blood to infuse back into the patient. A large amount ofdialysate, for example about 90-120 liters, is used by most hemodialysismachines to dialyze the blood during a single hemodialysis therapy. Thespent dialysate is then discarded. Hemodialysis treatment lasts severalhours and is generally performed in a treatment center about three timesper week.

Another type of hemodialysis therapy is regenerative hemodialysis. Thistherapy uses a hemodialysis system, which includes a cartridge fordialysate regeneration. One such cartridge is manufactured under thename REDY™ by Sorb Technology, Oklahoma City, Okla. In this system, thedialysate fluid flow path must be properly cleaned before thehemodialysis machine can be used on another patient. Also, the dialysatefluid flow path is not a closed system. In this regard, the dialysatefluid flow path is open to the atmosphere such that air borne pathogenscan contact the fluid in the system and foster the growth of bacteria insame. Consequently, contamination of such a dialysis system can beproblematic. Thus, the dialysate fluid exiting the REDY™ cartridge isnot suitable for peritoneal dialysis.

Peritoneal dialysis utilizes a sterile dialysis solution or “dialysate”,which is infused into a patient's peritoneal cavity and into contactwith the patient's peritoneal membrane. Waste, toxins and excess waterpass from the patient's bloodstream through the peritoneal membrane andinto the dialysatc. The transfer of waste, toxins, and excess water fromthe bloodstream into the dialysate occurs due to diffusion and osmosisduring a dwell period as an osmotic agent in the dialysate creates anosmotic gradient across the membrane. The spent dialysate is laterdrained from the patient's peritoneal cavity to remove the waste, toxinsand excess water from the patient.

There are various types of peritoneal dialysis therapies, includingcontinuous ambulatory peritoneal dialysis (“CAPD”) and automatedperitoneal dialysis. CAPD is a manual dialysis treatment, in which thepatient connects the catheter to a bag of fresh dialysate and manuallyinfuses fresh dialysate through the catheter and into the patient'speritoneal cavity. The patient disconnects the catheter from the freshdialysate bag and allows the dialysate to dwell within the cavity totransfer waste, toxins and excess water from the patient's bloodstreamto the dialysate solution. After a dwell period, the patient drains thespent dialysate and then repeats the manual dialysis procedure. Tubingsets with “Y” connectors for the solution and drain bags are availablethat can reduce the number of connections the patient must make. Thetubing sets can include pre-attached bags including, for example, anempty bag and a bag filled with dialysate.

In CAPD the patient performs several drain, fill, and dwell cyclesduring the day, for example, about four times per day. Each treatmentcycle, which includes a drain, fill and dwell, takes about four hours.Manual peritoneal dialysis performed by the patient requires asignificant amount of time and effort from the patient. This procedureleaves room for improvement and therapy enhancements to improve patientquality of life.

Automated peritoneal dialysis is similar to continuous ambulatoryperitoneal dialysis in that the dialysis treatment includes a drain,fill, and dwell cycle. However, a dialysis machine automaticallyperforms three or more cycles of peritoneal dialysis treatment,typically overnight while the patient sleeps.

With automated peritoneal dialysis, an automated dialysis machinefluidly connects to an implanted catheter. The automated dialysismachine also fluidly connects to a source or bag of fresh dialysate andto a fluid drain. The dialysis machine pumps spent dialysate from theperitoneal cavity, through the catheter, to the drain. The dialysismachine then pumps fresh dialysate from the dialysate source, throughthe catheter, and into the patient's peritoneal cavity. The automatedmachine allows the dialysate to dwell within the cavity so that thetransfer of waste, toxins and excess water from the patient'sbloodstream to the dialysate solution can take place. A computercontrols the automated dialysis machine so that the dialysis treatmentoccurs automatically when the patient is connected to the dialysismachine, for example, when the patient sleeps. That is, the dialysissystem automatically and sequentially pumps fluid into the peritonealcavity, allows for dwell, pumps fluid out of the peritoneal cavity, andrepeats the procedure.

Several drain, fill, and dwell cycles will occur during the treatment.Also, a smaller volume “last fill” is typically used at the end of theautomated dialysis treatment, which remains in the peritoneal cavity ofthe patient when the patient disconnects from the dialysis machine forthe day. Automated peritoneal dialysis frees the patient from having tomanually perform the drain, dwell, and fill steps during the day.Automated dialysis can improve the patient's dialysis treatment andundoubtedly improves the patient's quality of life, as compared to CAPD.

“Continuous flow” peritoneal dialysis (“CFPD”) systems have beencontemplated since the 1970's. These systems typically have an in fluidflow and an out fluid flow. That is, the dialysate flows in one catheterlumen, through the peritoneum and out another catheter lumen to thedrain line. The “spent” dialysate (waste laden dialysate) collects in adrain bag, which is discarded, or is fed into a household or otherdrain. Known CFPD systems typically use a volume of disalysate one timeand then discard it. In this regard, the volume of dialysate necessaryto carry out treatment for a continuous flow single use or pass systemcan be large in size rendering their daily use cost prohibitive. Forexample, the volume of dialysate can exceed 120 liters for single passCFPD systems.

Another type of a CFPD system is disclosed in U.S. Pat. No. 3,707,967.This system requires the use of a reconstitution device to remove wastefrom the dialysate after the dialysate has passed through the patient'speritoneum. In particular, the reconstitution device includes a urearemoval column that employs urease to enzymatically convert urea intoammonia. The ammonia must then be removed from the dialysate prior toreintroduction into the peritoneal cavity in order to ensure the healthand safety of the patient. However, the removal of ammonia can beproblematic and thus may not provide a failsafe measure. Moreover,additional sensors must be employed to monitor the removal of ammoniafrom the reconstitued dialysate. This can add to the complexity of thetherapy and thus increase the cost associated with same.

In general, CFPD is known to be more effective as compared to otherforms of peritoneal dialysis therapy including, for example, moreconventional forms of peritoneal dialysis therapies, such as CAPD andAPD which typically require multiple exchanges of fresh dialysate duringtreatment. As previously discussed, several drain, fill and dwell cyclesare typically performed during CAPD and APD. An example of amodification of the more conventional forms of peritoneal dialysistherapy is disclosed in U.S. Pat. No. 4,618,343. An apparatus isdisclosed that allows the peritoneal cavity of the patient to be filledwith a sterile dialysis liquid as in the case of CAPD. After a dwellperiod, the dialysis liquid retains metabolic waste from the patient'sblood. A portion of the dialysis liquid containing the metabolic wasteis then pumped out of the peritoneal cavity and passed through adialyzer to remove the metabolic waste from the dialysis liquid. Thedialysis liquid can then be pumped back into the peritoneal cavity forreuse.

Therefore, a need exists to provide improved dialysis systems. Thesystems should allow the patient to perform the procedure at homewithout the need for storing an inordinate amount of fresh dialysatebags. The systems should further be automated so that the procedure canbe largely performed at night while the patient sleeps.

SUMMARY OF THE INVENTION

The present invention relates to systems and methods for providingperitoneal dialysis. In particular, the present invention relates tocontinuous flow peritoneal dialysis that employs a single closed fluidpath along which dialysate can be circulated into, through and out of aperitoneal cavity of a patient in order to effectively remove acceptablelevels of solutes and excess water or ultrafiltrate from the patientduring treatment.

In general, the present invention includes a fluid circuit which iscoupled to the patient thereby defining a single closed fluid path alongwhich the dialysate can be circulated and thus reused during the entiretreatment. Preferably, the dialysate is circulated along the fluid pathin a continuous manner. In this regard, the amount of dialysatenecessary for effective treatment can be optimally minimized. In anembodiment, the present invention can utilize six liters or less ofdialysate during treatment. With this amount of reusable dialysate,effective treatment can be conducted over periods of at most 10 hours,preferably about 8 hours or less, more preferably about 7 hours or less.

Prior to reuse, the dialysate is cleaned as it circulates along theclosed fluid path. In an embodiment, the present invention includes acleaning device which is coupled to the closed fluid path. The cleaningdevice is capable of removing an acceptable level of solutes includinguremic toxins or other metabolic waste products that have passed fromthe patient to the dialysate during treatment. The amount of solutesremoved from the dialysate is necessary to maintain a diffusive gradientat a sufficient level such that solutes and ultrafiltrate can beeffectively removed from the patient upon reuse of the dialysate duringtreatment.

In this regard, it is believed that the dialysate does not necessarilyhave to be cleaned or regenerated to its initial fresh state prior toreuse. Rather, the dialysate, after cleaning, may retain someconcentration of solutes removed from the patient, particularly urea. Inan embodiment, the cleaning device employs a sorbent material, such ascarbon, to non-selectively remove a substantial portion of solutes fromthe dialysate. This can include, for example, toxins removed from thepatient, such as creatinine, uric acid, mid-range molecular weightconstituents, at least a portion of urea and other like low molecularweight constituents and the like. Preferably, the cleaning deviceincludes a binder material to selectively remove urea, phosphate and/orother like solutes.

Even after cleaning, if the dialysate retains, for example, a portion ofurea removed from the patient, it is believed that the dialysate can becirculated along the closed fluid path to remove solutes from thepatient at or exceeding therapy level standards, such as DOQI standards.It is believed that the available volume of therapy fluid includingdialysate can be controllably minimized, circulated and cleaned duringthe entire treatment to achieve clinically acceptable levels of soluteclearance. Further, it is believed that the systems and methods of thepresent invention can achieve better clearance levels as compared toknown therapies including, for example, APD.

The available volume therapy fluid can be influenced by a number offactors, such as the amount dialysate fed into the closed fluid path,the amount of ultrafiltrate added to the closed fluid path and theamount of additional other solutions that can be added to the closedfluid path to enhance the diffusive properties of the dialysate. In anembodiment, the therapy volume is controllably adjusted by the amount ofdialysate that is fed into the closed fluid path in addition to theultrafiltrate that passes from the patient into the closed fluid pathduring treatment. To compensate for the amount of ultrafiltrate, thevolume capacity of the closed fluid path can be variably adjusted duringtreatment. In this regard, the addition of ultrafiltrate to the fluidcircuit, in effect, increases the capacity to remove solutes by keepingthe additional volume in contact with the loop. In an embodiment, about1.5 liters or less of ultrafiltrate is utilized during therapy.

Additional other solutions can be added to the closed fluid path incontrolled amounts to further enhance the effectiveness of soluteremoval during therapy. In an embodiment, a solution that contains anosmotic agent, such as dextrose, can be added to the closed fluid pathin addition to the initial source of dialysate and the added source ofultrafiltrate. Preferably, about 3 liters or less of the additionalosmotic agent solution is added. The dextrose-based solution can beutilized to replenish the diffusive properties of the dialysate prior toreuse. In an embodiment, the dextrose-based solution contains aconcentrated amount of dextrose as compared to the amount of dextrose orother osmotic agent in the initial source of dialysate.

Further, it is believed that the available amount of therapy fluidnecessary for effective treatment can be minimized with increasedcleaning efficiency. In an embodiment, the present invention canutilize, in addition to carbon, binder or reactive materials which arecapable of selectively removing specific types of solutes from thedialysate as previously discussed. The binder materials can be utilizedto remove urea, phosphates or other desirable metabolic waste productsthat may be retained in the dialysate even after carbon treatment.Preferably, the combination of non-selective and selective cleaningagents can be utilized to remove up to about 70% or greater of urea andother like constituents from the dialysate.

An advantage of the present invention is to provide improved systems andmethods for providing dialysis therapy.

Another advantage of the present invention is to provide improvedsystems and methods for continuous flow peritoneal dialysis.

Yet another advantage of the present invention is to provide an optimaluse of dialysate during continuous flow peritoneal dialysis.

Yet still another advantage of the present invention is to minimizetreatment times while providing optimal use of the dialysate duringcontinuous flow peritoneal dialysis.

A further advantage of the present invention is to provide improvedsystems and methods for performing dialysis therapy which can be safelyand conveniently administered to a patient in a home setting.

Yet a further advantage of the present invention is to provide improvedsystems and methods of peritoneal dialysis that can effectively cleanspent dialysate such that it can be circulated and reused duringtreatment in order to minimize the amount of dialysate necessary foreffective treatment.

Additional features and advantages of the present invention aredescribed in, and will be apparent from, the following DetailedDescription of the Invention and the Figures.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 schematically illustrates a dialysis system according to anembodiment of the present invention.

FIG. 2 schematically illustrates a dialysis system according to anotherembodiment of the present invention.

FIG. 3 schematically illustrates a dialysis system according to afurther embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

In general, the present invention employs a single closed fluid pathalong which a minimal volume of therapy fluid can be circulated suchthat the therapy fluid can pass into, through and out of a peritonealcavity of a patient connected to the closed fluid path to effectivelyremove solutes, excess water and the like from the patient duringtreatment. In an embodiment, the available volume of therapy fluid caninclude about 6 liters or less of an initial source of dialysate. It isbelieved that the available volume of therapy fluid can be circulatedalong the closed fluid path to remove solutes from the patient at orexceeding clinically acceptable solute removal standards, such as theNational Kidney Foundation's DOQI levels. In an embodiment, acceptablesolute removal or clearance levels can be achieved over a period of 8hours or less, preferably 7 hours or less, during treatment.

For example, it is believed that a therapeutic level of clearances canbe achieved for urea, creatinine, phosphate, β2 microglobulin, the likeand combinations thereof. The clearance levels can include, for example,about 2.1 per week to about 2.6 per week for urea; about 72 liters(l)/week (wk) to about 90 l/wk for creatinine; about 3.5grams(g)/week(wk) for phosphate; about 600 milligrams (mg)/week (wk) forβ2 microglobulin, the like and combinations thereof. It should beappreciated that the clearance levels can be determined in any suitableway. For example, the urea clearance levels can be based on Kt/Vcalculations. In this regard, Kt/V is generally recognized in the art asa dimensionless index that corresponds to urea clearance.

As used herein, the term “continuous flow” or other like terms asapplied to dialysis therapy, such as peritoneal dialysis, means that thetherapy fluid including dialysate is constantly and simultaneouslyflowing into and out of the patient's peritoneum during treatment. Inthis regard, the dwell period of the dialysate inside the peritoneumassociated with typical peritoneal dialysis therapies, such as CAPD andAPD, is effectively eliminated.

Preferably, the therapy fluid is circulated in a continuous mannerduring treatment. However, it should be appreciated that fluid flow ofthe present invention can include any suitable level of intermittent,non-continuous batch, tidal and/or other like fluid flow in addition tocontinuous flow during treatment. For example, the present invention mayprovide for brief intermittent fluid flow, such as during the filling ofa pump chamber, the fluid loop, the patient and/or the like prior totreatment, brief periods of downtime or breaks in therapy and/or otherlike suitable conditions. In this regard, the present invention can becontrolled to provide a variety and number of suitable dialysistherapies, as desired. In an embodiment, the continuous flow into,through and out of the peritoneal cavity preferably occurs during themain therapy treatment, so that a dwell during a last bag, for example,does not detract from the continuous flow feature.

As used herein, the term “therapy fluid” or other like terms means anysuitable fluid or solution that can be used during dialysis therapy. Thetherapy fluids can include, for example, a fresh source of dialysatesolution that has not been used during therapy, a waste laden dialysatethat contains solutes, metabolic waste and the like removed from thepatient during therapy, a clean source of dialysate that has beencleaned by sorbent materials or the like, a source of ultrafiltrate thathas been passed from the patient to be mixed with the dialysate duringtreatment, a solution that includes an osmotic agent in a sufficientamount to enhance the diffusive properties of the dialysate when addedto the dialysate, other suitable solutions and combinations thereof.

In general, the present invention includes a fluid circuit which iscoupled to the patient thereby defining the single closed fluid pathinto which an effective amount of a fresh source of dialysate can beinitially added. The dialysate can then be circulated, preferably in acontinuous manner, and cleaned along the closed fluid path and thuscontinually reused to remove solutes, excess water and the like from thepatient.

It is believed that the dialysate does not necessarily have to becleaned or regenerated to its original fresh state prior to reuse.Rather, the dialysate, after cleaning, may retain some concentration ofsolutes that was removed from the patient during therapy. This isparticularly relevant to the removal of urea or other like solutes.

In this regard, urea is typically removed by employing an enzymaticprocess that converts urea into by-products, such as ammonia. Theby-products can then be removed. However, from a patient health andsafety perspective, this type of cleaning process would necessarilyrequire additional components, such as sensors or the like, to ensurethat the by-products, particularly ammonia, have been effectivelyremoved prior to recirculation into, through and out of the patient.Even if urea or other like solutes are not completely removed from thedialysate or removed to typically acceptable levels prior to reuse, itis believed that effective and clinically acceptable levels of soluteremoval can be achieved upon reuse of the dialysate during treatment.

To compensate for the concentration of solutes that may be retained inthe dialysate prior to reuse, the present invention can controllablyminimize, circulate and clean the available volume of therapy fluidduring the entire treatment. The available volume of therapy fluid canbe controllably adjusted based on a number of parameters, such as theamount of initial source of dialysate pumped into the closed fluid path,the amount of ultrafiltrate added to the closed fluid path, the amountof additional other solutions that include osmotic agents and/or othersuitable constituents to enhance the diffusive properties of thedialysate, and other like parameters as described in detail below.

The available volume of therapy fluid necessary for effective treatmentcan also be influenced by the efficiency of the cleaning process. Asdescribed below, carbon or other like materials can be utilized to cleanthe dialysate as it circulates along the closed fluid path. The cleaningefficiency can be increased with the use of materials that canselectively remove solutes in combination with the non-selective removalcapabilities of carbon or other like materials. This can be performedwithout the use of an enzymatic conversion process that producesreaction by-products, such as the conversion of urea into ammonia, thuseffectively eliminating the need to remove the by-products from thesolution prior to reuse.

The dialysis systems and methods of the present invention provideadvantages, it is believed, compared to existing dialysis systems andtherapies, such as clinical advantages, economic advantages, and qualityof life advantages, for example. It is believed that the presentinvention has clinical advantages, such as, improved blood pressurecontrol, improved fluid volume control, improved therapy performance asassessed by known clinical standards, such as the National KidneyFoundation's DOQI standard, higher clearance efficiency rates, lowerglucose absorption, glucose profiling and ultrafiltrate management,reduced catheter channeling and/or the like.

It is also believed that the present invention provides economicadvantages, such as, reduced therapy cost. Further, it is believed thatpresent invention has quality of life advantages, such as, increasedawake time free from dialysis devices, improved patient access, reducedcomplexity, reduced self-administration of drugs, reduced therapytraining, elimination of the need for having a home waterinfrastructure, a reduced amount of fluid that the patient must handleand manage, simpler prescriptions, elimination of patient transportationto dialysis centers and/or the like.

It is believed that the continuous flow dialysis systems and methods ofthe present invention more closely simulate and replace continuouskidney functioning as compared to typical intermittent dialysistherapies. This, in turn, can contribute to improved clinical outcomeswhile minimally impacting the patient's lifestyle. The efficiency andconvenience of the present invention provides patients with a renalreplacement therapy that is relatively unrestrictive. This allowspatients to have greater freedom from limitations experienced byconventional dialysis devices and therapies. The present invention canprovide easier entrance into early dialysis therapy because the systemcan enable the physician to monitor therapy while minimally impactingthe patient's lifestyle.

The continuous flow peritoneal dialysis therapy of the present inventioncan include a variety of different components and configurations toeffectively remove solutes from the patient with a minimal volume oftherapy fluid and within an optimal time frame as previously discussed.As shown in FIG. 1, the present invention includes a fluid circuit 10 influid communication with a catheter 12 insertable within a patient 14undergoing peritoneal dialysis. This defines a single closed fluid path16 along which dialysate can be fed into and circulated, preferably in acontinuous manner, to remove excess water and solutes including toxinsand metabolic waste and the like from the patient as the dialysatcpasses into, through and out of the peritoneal cavity of the patient.

Catheter

Any suitable catheter or other medically acceptable access device can beutilized. In a preferred embodiment, a dual lumen catheter can be used.The dual lumen catheter provides for circulation of the therapy fluidalong the fluid path allowing flow into, through and out of theperitoneal cavity of the patient. To this end, the dual lumen catheteris implanted in the patient. An example of a catheter for use in thedialysis system of the present invention is disclosed in U.S. patentapplication Ser. No. 09/689,508, filed on Oct. 12, 2000, now U.S. Pat.No. 6,976,973, and entitled “Peritoneal Dialysis Catheter,” thedisclosure of which is incorporated herein by reference. However, itshould be noted that two single lumen catheters can be used as long asthere is an inflow and outflow path for circulation of fluid through theperitoneum.

Dialysate

The fresh or initial source of dialysate can include any suitable amountand type of solution that can be effectively used to dialyze a patient.As previously discussed, the present invention can meet and/or exceedclinically acceptable solute removal levels while utilizing a minimalvolume of therapy fluid. In an embodiment, the volume of dialysate usedduring therapy is about 6 liters or less. It is believed that the lowerrange limit of the volume of dialysate can reach volume levels as low asabout 5 liters or even lower as the cleaning efficiency of the dialysatein circulation along the closed fluid path is increased.

The dialysate solution can be fed into the closed fluid path in avariety of suitable ways. In an embodiment, the entire volume of thefresh source of dialysate is fed into the closed fluid loop at thebeginning of therapy. This can be performed by any suitable pumpingmechanism. The entire volume can be contained in and fed from one ormore suitable solution containers 18, such as conventional dialysissolution bags that are about 6 liters in capacity. Alternatively, thedialysate can be generated and fed from an on-line dialysate generationsystem. In an embodiment, the dialysate can be intermittently and/orcontinuously fed into closed fluid path during the entire therapy at anysuitable flow rates and/or amounts.

The dialysate solution can include any suitable type of dialysatesolution. In an embodiment, the fresh source of dialysate solutionincludes an osmotic agent, such as dextrose or the like in any suitableamount. It should be appreciated that the amount of dextrose necessaryfor effective therapy may vary from patient to patient. In this regard,the amount of osmotic agent can vary and include any clinicallyacceptable level, such as about 1.5% by weight, about 2.5% by weight,about 3.5% by weight, about 4.25% by weight or greater to meet thespecific needs of the patient. The dialysate can include any suitableamount and type of electrolytes in addition to the osmotic agentincluding, for example, calcium, sodium, potassium, like constituentsand combinations thereof.

Cartridge

As shown in FIG. 1, the present invention can include any suitable typeof device 20 which utilizes any suitable amount and type of material toeffectively clean the therapy fluid as it circulates along the closedfluid path. This facilitates the reuse of the therapy fluid to removeeffective levels of solutes, excess water and the like from the patientduring therapy. In an embodiment, the cleaning device includes amaterial that is capable of non-selective removal of solutes from thetherapy fluid that have been removed from the patient during therapy.Preferably, the material includes any suitable sorbent material, such ascarbon, activated carbon and/or other like material that is containedwithin a suitable housing, such as a cartridge, in any acceptablemanner. As previously discussed, it is believed that the non-selectiveremoval of solutes from the dialysate can be used, on its own, to cleanthe dialysate such that effective removal of solutes and excess waterfrom the patient can occur upon reuse of the dialysate.

In an embodiment, the present invention can include other materials inaddition to those types of materials which can non-selectively removesolutes from the dialysate. The additional other materials include, forexample, materials that can selectively remove certain solutes or thelike from solution. In an embodiment, the additional materials include abinder material capable of selectively removing urea, a binder materialcapable of selectively removing phosphate and/or the like.

In general, the binder materials chemically bind the solutes, such asurea, to remove them from the dialysate or other suitable fluid mediumas described below in greater detail. This process does not result inthe release of harmful substances as reaction by-products as compared toan ezymatic process. For example, urease is known to enzymaticallyconvert urea into ammonia. However, ammonia must then be removed fromthe dialysate prior to reintroduction into the peritoneal cavity inorder to ensure the health and safety of the patient. With the use ofbinder materials, the dialysate can be reintroduced into the peritonealcavity without further processing of the dialysate as a result of thebinder process. As previously discussed, the use of materials capable ofselective removal of solutes, particularly urea, can be used to enhancethe cleaning efficiency of the system of the present invention such thatless therapy volume would be needed to provide effective therapy.

The materials that can selectively remove solutes from solution, such asbinder materials, can include a variety of suitable and differentmaterials including, for example, polymeric materials that are capableof removing nitrogen-containing compounds, such as urea, creatinine,other like metabolic waste and/or the like in solution. In general,these types of materials contain a functional group(s) that chemicallybinds with urea or other like solutes.

For example, U.S. Pat. Nos. 3,933,753 and 4,012,317, each incorporatedherein by reference, disclose alkenylaromatic polymers containingphenylglyoxal that can function to chemically bind urea. In general, thephenylglyoxal polymeric material is made via acetylation performed in,for example, nitrobenzene followed by halogenation of the acetyl groupand treatment with dimethylsulfoxide as disclosed in U.S. Pat. Nos.3,933,753 and 4,012,317. Another example of a polymeric material that iscapable of selectively removing solutes, such as urea, from solutionincludes polymeric materials that contain a tricarbonyl functionalitycommonly known as ninhydrin as disclosed in U.S. Pat. No. 4,897,200,incorporated herein by reference. However, it should be appreciated thatthe present invention can include any suitable type of material orcombinations thereof to selectively remove solutes, such as urea, fromsolution as previously discussed.

The cleaning cartridge of the present invention can include a number ofcomponents in addition to the materials capable of removing solutes fromthe dialysate. For example, the cleaning cartridge may have thecapability to remove all or a portion of electrolytes, such as sodium,potassium, or the like, from the dialysate solution. In this case, anadditional source of electrolytes in solution may be needed to replenishthe dialysate after it has been cleaned. The cartridge may also beconfigured to release bicarbonate or the like into the system dependingon the type of cleaning material used. This can facilitate pH regulationof the dialysate. As necessary, the cartridge may include a filter toprevent proteins, particulate matter or like constituents from leachingor exiting from the cartridge and into the dialysate.

Treatment Conditions

During treatment, the therapy fluid, including the dialysate, iscirculated, preferably in a continuous manner, and cleaned along theclosed fluid path such that it can be continually reused to provideeffective treatment of the patient. The therapy fluid can be circulatedat any acceptable flow rate. In an embodiment, the fluid flow rate inthe closed fluid loop can be varied up to about 300 ml/min, preferablyabout 100 ml/min or less. At these flow rates, the present invention canprovide effective treatment to the patient in 8 hours or less,preferably 7 hours or less. In an embodiment, the systems and methods ofthe present invention are conducted during the night. Preferably, thetreatment therapy of the present invention is combined with an all daydwell period where a suitable amount of dialysate has dwelled within thepatient. In an embodiment, the all day dwell includes about 2 liters orless of dialysate. It should be appreciated that this volume can varyfrom patient to patient depending on the specific needs of the patient.

The peritoneal dialysis of the present invention can be performed in avariety of suitable manners. In an embodiment, the entire volume of thefresh source of dialysate is fed into the fluid circuit at the beginningof the treatment. In this regard, the peritoneal cavity of the patientis filled with about 3 liters of the fresh source of dialysate solutionand the remaining portion of the dialysate is pumped into the fluidcircuit before the dialysate is circulated during treatment. It shouldbe appreciated that the initial fill volume of dialysate within thepatient's peritoneal cavity may vary from patient to patient.

Alternatively, the treatment period can be performed over a number oftreatment cycles. In an embodiment, the treatment period can include twoseparate treatment cycles. In each cycle, about any suitable portion ofthe fresh source of dialysate is initially fed into the fluid circuitand then circulated for an effective treatment cycle period of about 4hours or less. After the first cycle, the entire volume of therapy fluidincluding the dialysate in addition to any amount of ultrafiltrate oradditional solutions that were added to the fluid circuit duringtreatment is drained from the fluid circuit. Once drained, the remainingportion of fresh dialysate is fed into the fluid circuit and circulateduntil treatment is complete.

Cycler

In an embodiment, the fresh source of dialysate can be pumped into andcirculated along the fluid circuit and drained from the fluid circuitafter each treatment cycle with the use of a device which is commonlyknown in the art as a cycler (not shown). As used herein, the term“cycler” or other like terms refers to a pressure driven, diaphragm-typevolumetric displacement pump coupled to a fluid path or paths in anysuitable manner such that fluid flow can be automatically controlled.The cycler can determine the volume of liquid delivered as thedifference in the volume of a pumping chamber before and after a pumpingstroke. The pumping chamber, in general, includes two parts separated bya flexible diaphragm with air on one side and fluid on the other.Increasing the air pressure pushes liquid out of the chamber expandingthe volume on the air side.

It should be appreciated that the cycler can include any suitable numberand types of components, such as pumps and valves, coupled to anysuitably designed fluid circuit to provide efficient and effectiveautomatic control of therapy fluid flowing into and out of the closedfluid path 16. For example, the cyclers typically applied duringautomated peritoneal dialysis and suitable modifications thereof can beemployed.

Examples of a cycler are disclosed in U.S. Patent Applications:“Peritoneal Dialysis Systems and Methods Employing a Liquid Distributionand Pumping Cassette That Emulates Gravity Flow,” filed Mar. 3, 1993,Ser. No. 08/027,328, issued as U.S. Pat. No. 5,350,357; “Liquid PumpingMechanisms for Peritoneal Dialysis Systems Employing Fluid Pressure,”filed Mar. 3, 1993, Ser. No. 08/027,485, issued U.S. Pat. No. 5,431,626;“Peritoneal Dialysis Systems and Methods Employing Pneumatic Pressureand Temperature-Corrected Liquid Volume Measurements,” filed on Mar. 3,1993, Ser. No. 08/026,458. issued as U.S. Pat. No. 5,474,683; “ImprovedUser Interface and Monitoring Functions for Automated PeritonealDialysis,” filed Mar. 3, 1993, Ser. No. 08/025,531, issued as U.S. Pat.No. 5,438,510; “Improved User Interface for Automated PeritonealDialysis Systems,” filed Mar. 3, 1993, Ser. No. 08/025,547, issued asU.S. Pat. No. 5,324,422; and “Peritoneal Dialysis Cycler,” filed Mar. 3,1993, Ser. No. 08/006,426, issued as U.S. Pat. No. D 351,470, thedisclosures of all of which are incorporated herein by reference. Itshould be appreciated that the cycler can be coupled to the continuousflow system in any suitable manner, such as with the use of any suitabledisposable cartridge that can be used as a fluid interface between thepatient and the fluid circuit to readily and easily couple the patientto the fluid circuit as typically employed during automated peritonealdialysis and/or modifications thereof.

After treatment, the therapy fluid is removed from the fluid circuitthrough a discharge path 22 which is coupled to the fluid circuit. Thetherapy fluid can be discharged in any suitable manner, such as by anysuitable pump mechanism coupled to the fluid discharge path. Thedischarged therapy fluid can be disposed of or alternatively can beregenerated for prior use.

Additional Osmotic Agent

Referring now to FIG. 2, the present invention can include a source offluid 28 in addition to the dialysate and the ultrafiltrate which can beadded to the fluid circuit during treatment. The additional fluid sourcecan include one or more solutions, such as an aqueous solution thatcontains an osmotic agent, such as dextrose or the like, in a sufficientamount in order to replenish the diffusive properties of the therapyfluid during treatment. The amount of osmotic agent can include about2.5% by weight, about 3.5% by weight, about 4.25% or greater by weightof the suitable amounts and combinations thereof. The additionalsolution source can also include an acceptable level and type of otherconstituents, such as electrolytes including calcium, magnesium, sodium,the like and combinations thereof, in addition to the osmotic agent. Inan embodiment, the amount of osmotic agent solution added to the fluidcircuit is about 3 liters or less, preferably about 2 liters or less.The osmotic agent solution can be continuously fed or intermittently fedinto the closed fluid path on a monitored basis in any suitable manner.

It should be appreciated that the amount and type of osmotic agentsolution necessary to facilitate effective treatment can vary frompatient to patient. In an embodiment, a solution with a relatively highlevel of osmotic agent and electrolytes as compared to the existingtherapy fluid can be fed to the fluid circuit in volumetric amounts ofabout 1 liter or less. In an embodiment, the solution concentrate ofosmotic agent and electrolytes can include an osmotic agent, such asdextrose, at about 4.25% or greater by weight and concentration levelsof electrolytes that are higher than existing levels in the therapysolution such that levels in the therapy solution can be adjusted toachieve optimal and physiological acceptable levels prior to reuse.

In an embodiment, components of the solution concentrate can beindividually infused into the fluid circuit. The components can includethose types of constituents typically contained in dialysate solutionsincluding, for example, an osmotic agent, such as dextrose, bicarbonate,sodium, calcium, magnesium, like constituents and combinations thereof.The amount of individual components fed into the fluid circuit can beregulated and controlled in any suitable manner.

For example, a sensing device (not shown) can be coupled to the systemof the present invention which can be utilized to provide on-line andreal-time monitoring of the specific levels of the components duringtreatment. The sensor can then be configured to communicate with theinfusion device (not shown) of each of the components to regulate theflow of components into the fluid circuit. This can also be utilized tomonitor the level of ultrafiltrate removed from the patient. If moreultrafiltrate is desired, the sensor can be adapted to communicate witha pump to increase the flow of dextrose and thus, increase ultrafiltrateremoval from the patient. In an embodiment, the amount of the individualcomponents added during therapy can be regulated based on customizedtherapy profiles associated with each of the components.

In an embodiment, the available volume of therapy solution can includethe initial amount of fresh dialysate, the amount of ultrafiltrateand/or other additional solutions, such as the dextrose-based solutionsas previously discussed. Instead of variably increasing the volumecapacity of the fluid circuit, the fluid circuit volume capacity canremain relatively constant during treatment. In this regard, an amountof therapy fluid is discharged from the fluid circuit at a rateapproximate to the infusion of the dextrose-based solution and transportof ultrafiltrate into the fluid circuit. Preferably, the fluid circuitvolume capacity can be fixed in this way as the cleaning efficiency ofthe therapy solution is increased. In this regard, a variable increasein the available volume of therapy fluid is not necessary for effectivetreatment.

Reservoir

In an embodiment, the present invention includes a reservoir 24 which iscoupled to the fluid circuit. This can provide a variable increase involume capacity of the fluid circuit during treatment. In this regard,the ultrafiltrate which passes from the patient and into the fluidcircuit can be mixed with the dialysate and thus increase the volume oftherapy fluid available for effective treatment.

As previously discussed, the addition of ultrafiltrate to the dialysate,in effect, increases the capacity to remove solutes by keeping theadditional volume in contact with the fluid loop. This can facilitatethe cleaning process and thus effectively minimize the volume of freshdialysate that is necessary for treatment purposes. As used herein, theterm “ultrafiltrate” or other like terms means the excess water that isremoved from the patient as the dialysate acts to dialyze the patient.It should be appreciated that the reservoir can include any suitablecomponents, such as any suitable container coupled to a pump which canact to variably increase the volume of the fluid circuit in any suitablemanner. The container can include any suitable type of container suchthat a portion of fluid from the fluid loop can be effectively pumpedinto and out the container during therapy. Preferably, the accumulatorcontainer is not flexible. In this regard, fluid pumped into the fluidloop is designed to be pushed by pumps. Therefore, it would be difficultto control or regulate flow rates through the fluid circuit with aflexible container acting as an accumulator or variable reservoir.

As shown in FIG. 3, the present invention includes a fluid circuit 30 influid communication with a catheter 32 insertable within a patient 34undergoing peritoneal dialysis. A single closed fluid path 36 is therebydefined. A source of dialysate is provided in a container 38 coupled tothe fluid circuit 30. From the container, the dialysate can be pumpedinto and circulated along the fluid circuit to remove metabolic wasteand/or ultrafiltrate from the patient as it passes into, through and outof the patient. A cleaning device 40 can also be coupled to the fluidcircuit to clean the dialysate as it circulates along the fluid circuit30 as previously discussed.

At the beginning of therapy, at least a portion of the dialysate ispumped into the fluid circuit 30 to fill the peritoneal cavity of thepatient. The remaining portion, if any, of the dialysate can be pumpedinto the fluid circuit at a later stage in the therapy. As the therapycontinues, a portion of the therapy fluid that has circulated along thefluid circuit can be pumped into the container 38 as the volume intherapy fluid increases due to, for example, the addition ofultrafiltrate to the fluid circuit that has been removed from thepatient and/or an additional amount of osmotic agent solution (notshown) added to the fluid circuit 30 as previously discussed. At least aportion of the container 38 can be filled with the therapy fluid in acontinuous manner or intermittently. At least a portion of the therapyfluid in the container 38 can be subsequently pumped back into the fluidcircuit 30. Any suitable amount of therapy fluid can be sent to orpulled from the container at any suitable time intervals to adjust thevolume of available therapy fluid. This allows the portion of therapyfluid to be pumped into or out the container while the remaining portionof the therapy fluid in the fluid circuit 30 continues to circulatealong the fluid circuit 30.

It should be appreciated that any suitable volume of therapy fluid canbe pumped into or out of the container to compensate for a change involume of therapy fluid during therapy. The fluid flow into or out ofthe container 38 and in circulation along the fluid circuit can becontrolled at any suitable flow rates and by any suitable type andnumber of pumps 39. The pumps can be coupled to the system via a cycleror one or more of the pumps can be separately coupled to the system. Inan embodiment, the flow of fluid into or out of the container can becontrolled at a flow rate of about 75 ml/min while the flow of fluidcirculating along the fluid circuit can be controlled at about 250ml/min as shown in FIG. 3.

It should be appreciated that the systems and methods of the presentinvention can utilize any suitable number and type of components tofacilitate effective treatment of the patient by enhancing quality oflife, economic, treatment efficiency and other like treatmentconditions. For example, the present invention can employ the use of anynumber and acceptable type of pumps adapted in any suitable manner suchthat therapy solutions, including dialysate, can be effectively fedinto, circulated within and drained from the single closed fluid loopconnected to the patient.

Monitors

In an embodiment, the dialysis system of the present invention is aclosed, sterile system in order to prevent air, moisture and otherenvironmental contaminants from entering into the closed fluid loop. Inthis regard, the present invention can include a variety of differentcomponents to monitor for levels of contaminants in the system. Forexample, the present invention can include a gas sensor to monitor foratmospheric gases including oxygen and carbon dioxide. If detected, thepresent invention can include any suitable device to remove the gas fromthe system of the present invention such that the gas can be vented tothe atmosphere.

In an embodiment, temperature sensors are provided at desired locationsalong the closed fluid loop. The temperature sensors monitor variousfluid temperatures which can be utilized to control the fluidtemperatures associated with the heater. When two or more heaters, suchas an infrared heater and a plate heater, are provided in the dialysissystem, the system in an embodiment includes separate temperaturesensors for each heater so that each heater can be controlledindividually.

The present invention in an embodiment also includes various othersensors to monitor various other parameters. For example, fluid pressuresensors can be electrically coupled to or otherwise communicate with acontroller to provide a signal that indicates the respective fluidpressure at certain locations along the closed fluid path. Based on thesignals from the pressure sensors, the controller can operate the fluidpumps and valves to obtain and maintain desired fluid pressures and flowrates in the loop running to, through and from the patient.

In an embodiment, the pressure sensors are non-invasive pressuresensors. These pressure sensors do not physically contact (and possiblycontaminate) the medical fluid or dialysate. Of course other fluid flowmeasurement devices, such as flow rate sensors, pressure gauges,flowmeters, pressure regulators, orifice plates, mass flow meters,capacitative fluid sensor, or other flow measuring devices known tothose of skill in the art may be provided in any suitable quantity andadapted to the fluid circuit.

In an embodiment, a flow measurement or volume sensing device isprovided, which includes a capacitance sensor that measures the volumeof fluid pumped through a chamber, such as a pump chamber (not shown).An example of the capacitive fluid sensor is disclosed in the patentapplication entitled, “Capacitance Fluid Volume Measurement,” Ser. No.10/054,487, incorporated herein by reference.

The capacitance C between two capacitor plates changes according to thefunction C=k×(S/d), wherein k is the dielectric constant, S is thesurface area of the individual plates and d is the distance between theplates. The capacitance between the plates changes proportionallyaccording to the function 1/(R×V), wherein R is a known resistance and Vis the voltage measured across the capacitor plates.

In an embodiment of the capacitance sensor, the sensor operates incooperation with a cycler pump chamber. The cycler pump chamber in anembodiment includes shells or walls defining a fixed and known volumeand a pair of flexible membranes operating between the shells, whichexpand to fill with fluid and contract to discharge fluid. Thecapacitance sensor includes capacitor plates disposed on opposite sidesof the pump chamber. As the volume of fluid in the chamber or fluid pumpchanges (i.e., the pump chamber fills or empties), the dielectricproperty of the varying fluids between the capacitance plates changes.For example, the combined dielectric constant of dialysate and airchanges as dialysate replaces air (or air replaces dialysate) within theconstant volume shells of the chamber. This change in the overalldielectric constant affects a change in the capacitance between the twoplates, which causes a change in voltage across the capacitance plates,wherein a corresponding change in voltage can be sensed by a voltagesensing device. The controller monitors the change in voltage by thevoltage sensing device and correlates (after a calibration of thesensor) the capacitance change to an amount of fluid pumped throughchamber.

In another embodiment, the volume of the chamber or the pump chamber canvary, e.g., by movement of one or both the shells of the chamber. Inthis embodiment, the capacitance between the capacitor plates changesdue to a changing distance d between the plates and/or a changingsurface area S of one or more of the plates, wherein the dielectricconstant k is static because only one fluid resides at all times betweenthe capacitor plates. In a further alternative embodiment of themeasurement device, the capacitance C between the capacitor plateschanges based on any combination of all three of a change in dielectricconstant k, distance d and surface area S.

The controller collects a multitude of voltage signals from capacitancechanges due to a plurality of chamber fill and drain cycles, wherein thecontroller calculates a total volume of medical fluid pumped over alength of time or number of pump cycles. The capacitance sensor monitorsthe medical fluid, e.g., dialysate, flow into or from the pump chamberon a real time basis, and in a non-invasive manner.

The capacitance sensor enables the dialysis system to maintain thevolume of fluid that is provided to the patient at desirable amounts andflow rates. Maintaining the fluid flow to the patient within desiredlevels is particularly advantageous for peritoneal dialysis therapies.

It is also desirable to maintain the fluid provided to the patient atphysiologic levels. Physiologic control, such as sensing and/oradjusting parameters of the fluids, can take place at various locationsin the dialysis system. To this end, the system can include anycombination of a number of different types of physiologic level sensors.For example, the system can include one or more pH sensors. In oneimplementation, the cartridges explained above in connection with FIG. 1can include a pH sensor that helps to adjust the fluid so that it ismaintained at a desired physiologic level.

Heater

The present invention can include a fluid heater which can adaptedly actto heat the fluid in the closed fluid loop to a desired temperature forsupplying the fluid to the patient. In this regard, the temperature ofthe dialysate at initial system fill

can be quite low, such as 5° C. to 10° C. if the fluid is stored in coldambient temperature. In an embodiment, the fluid heater is an in-lineheater (continuous flow heater) that heats the fluid to the desiredtemperature as the fluid flows continuously past the heater. In otherembodiments, heaters other than in-line heaters can be used, forexample, bulk heaters, a dual heater and the like.

In an embodiment, the fluid heater is a dual heater (not shown),including an infrared heater and a plate heater. An example of such adual heater is disclosed in a patent application entitled, “MedicalFluid Heater Using Radiant Energy,” Ser. No. 10/051,609, now U.S. Pat.No. 7,153,285, and incorporated herein by reference. Both the infraredheater and the plate heater are in-line heaters that heat the medicalfluid that flows continuously past the heaters. The radiant energy orinfrared heater emits infrared energy that is directed to and absorbedby the fluid in the patient loop, thereby heating the fluid. The radiantenergy or infrared heater is a primary or high capacity heater which canheat a relatively large volume of cold fluid to a desired temperature ina short period of time.

The plate heater is a secondary or maintenance heater which has arelatively lower heating capacity relative to the infrared heater. Theplate heater uses electrical resistance to increase the temperature of aplate that in turn heats the fluid flowing near the plate.

The heater, which includes both high and low capacity heaters, providesan efficient heater design that accommodates various fluid heatingrequirements. For example, the radiant or infrared heater isparticularly useful for quickly heating cool dialysate (high heat energydemand) that is supplied to the dialysis system, such as at the initialsystem fill or if there is severe heat loss during dialysis treatment.The temperature of the dialysate at initial system fill can be quitelow, such as 5° C. to 10° C. if the fluid is stored in cold ambienttemperature.

The plate heater is particularly useful to maintain a desiredtemperature (lower heat energy demand) of the fluid being supplied tothe patient, e.g., due to a normal amount of heat loss during dialysistreatment. The infrared heater provides for the high heat demand in asmall amount of fluid exposure space, while the plate heater providesfor maintenance heat demand and requires a lesser amount of input energycompared to the infrared or radiant heater. Furthermore, the heatingcapacity of the heater is increased if both the infrared and plateheaters are used together to heat the fluid.

The infrared heater and the plate heater can be arranged in variousconfigurations relative to each other. The heaters in an embodiment arearranged so that the fluid passes by the heaters sequentially (e.g.,first the radiant or infrared heater and then the plate heater or viceversa). In another embodiment, the fluid passes by the heaterssimultaneously (both heaters at the same time). The fluid flow path pastthe heaters can be a common flow path for both heaters or includeindependent flow paths for each heater. Besides radiant or infraredelectrical resistance heating, other types of heating such asconvective, microwave, infrared (“IR”) or inductive heating may be used.

Filter

The heater can include a number of different components. For example,the heater can include a filter made from any suitable material in anysuitable filter size. The filter can be made of any suitable materialand include any suitable filter size. In an embodiment, the filter isabout 0.3 microns in size, preferably about 0.22 microns. This meansthat the filter can remove solutes in solutions that are about 0.3microns in size or larger with a filter size of about 0.3 microns orabout 0.22 microns in size or larger for a filter size of about 0.22microns. The filter can act in a variety of different ways to enhancethe performance of the dialysis system of the present invention.

For example, the filter can be used in place of typical UVdecontamination techniques or the like to disinfect the therapy fluidprior to passing into, through and out of the patient. This caneffectively eliminate, or at least greatly reduce, infection in thepatient as a result of the treatment, such as peritonitis which can becontracted through touch contamination during therapy.

It should be appreciated that the filter(s) can be coupled to the fluidcircuit at any suitable position. On the patient in flow side, thefilter can act to disinfect the dialysate prior to passing into thepatient as previously discussed. The filter(s) can also be coupled tothe discharge pathway. In this location, the filter can be used toremove nutrients from the therapy fluid prior to discharge. The filtercan then be cleaned by, for example, back flushing with a suitablesolution, to remove the filtered nutrients for reuse and reintroductioninto the patient. The filter can be constructed in any suitable way toenhance its filtering efficiency.

It should be appreciated that the fluid path, fluid circuit, fluid loopand/or the like of the present invention can be made of one or morefluid lines interconnected in any suitable manner. The fluid lines caninclude any suitable material including a flexible, sterile and inertplastic, such as polyethylene, polystyrene, polypropylene, polyvinylchloride and/or combinations thereof. In general, the fluid lines aretransparent such that the fluid flow through the lines can be visuallyobserved.

It should be understood that various changes and modifications to thepresently preferred embodiments described herein will be apparent tothose skilled in the art. Such changes and modifications can be madewithout departing from the spirit and scope of the present invention andwithout diminishing its intended advantages. It is therefore intendedthat such changes and modifications be covered by the appended claims.

1. A system for providing peritoneal dialysis to a patient, the systemcomprising: a catheter having an inflow lumen and an outflow lumen incommunication with a peritoneal cavity of the patient; a fluid circuitin fluid communication with the catheter thereby defining a closed fluidpath capable of circulating fluid into, through and out of theperitoneal cavity; a supply of dialysate coupled to the fluid circuit; acycler configured for continuously pumping the dialysate into the fluidcircuit and circulating the dialysate during a treatment period alongthe closed fluid path to remove a therapeutically effective amount ofsolutes and ultrafiltrate from the patient; a reservoir coupled fluidlyto the fluid circuit via a pump and branching off the closed loop formoving fluid via the pump at a controlled flowrate from the fluidcircuit to the reservoir and from the reservoir to the fluid circuit; acleaning device coupled to the fluid circuit wherein the cleaning deviceis capable of removing an amount of the solutes from the dialysateincluding at least a portion of urea; and a discharge path coupled tothe fluid circuit allowing the fluid circuit to be drained of fluidafter the treatment period.
 2. The system of claim 1 further comprisingat least one pressure sensor connected to the closed fluid path.
 3. Thesystem of claim 1 further comprising a heater for warming the dialysate.4. The system of claim 1 further comprising a flow volume sensing deviceoperably coupled to the closed fluid path.
 5. The system of claim 4wherein the cleaning device includes a sorbent material including atleast one of carbon and activated charcoal.
 6. The system of claim 5wherein the cleaning device does not include a material capable ofselectively removing urea.
 7. The system of claim 1 further comprising asupply of osmotic fluid coupled to the fluid circuit.
 8. The system ofclaim 7 wherein the supply of osmotic fluid couples to the fluid circuitat a point nearer to the patient that the supply of dialysate.
 9. Asystem for providing peritoneal dialysis to a patient, the systemcomprising: a catheter having an inflow lumen and an outflow lumen incommunication with the patient's peritoneal cavity; a fluid circuit influid communication with the catheter thereby defining a closed fluidpath capable of circulating therapy fluids into, through and out of theperitoneal cavity; a first supply of a first therapy fluid, the firsttherapy fluid including a dialysate coupled to the fluid circuit; acycler that pumps the dialysate into the fluid circuit and circulatesthe dialysate along the closed fluid path during a treatment period toremove a therapeutically effective amount of solutes and ultrafiltratefrom the patient; a second supply of a second therapy fluid, the secondtherapy fluid including an osmotic agent, the second supply coupled tothe fluid circuit separately from the first supply and configured in thesystem for rapid delivery to the patient; a cleaning device coupled tothe fluid circuit wherein the cleaning device is capable of removingsolutes from the fluids including a therapeutically effective portion ofurea from the therapy fluid as the therapy fluid circulates along theclosed fluid path; and a discharge path coupled to the fluid circuitallowing the fluid circuit to be drained of the therapy fluid at aneffective rate to compensate for an increase in therapy fluid volume inthe fluid circuit due to the second supply of fluid and theultrafiltrate.
 10. The system of claim 9 wherein the second supply iscloser to the inflow lumen than the first supply.
 11. The system ofclaim 9 further comprising a pressure sensor operably connected to theclosed fluid path.
 12. The system of claim 9 further comprising at leastone heater for warming the therapy fluids.
 13. The system of claim 9further comprising a filter capable of removing particles at least 0.22microns in size.
 14. The system of claim 9 wherein the second therapyfluid includes an osmotic agent solution is selected from the groupconsisting of a 2.5% dextrose-based solution, a 3.5% dextrose-basedsolution, a 4.25% dextrose-based solution, a greater than 4.25%dextrose-based solution and combinations thereof.
 15. The system ofclaim 9 wherein the second therapy fluid includes an osmotic agentsolution that contains about 4.25% or more of dextrose and aconcentration of one or more electrolytes higher than a level ofelectrolytes in the first fluid.
 16. The system of claim 9 wherein thecleaning device is capable of non-selectively removing solutes from thetherapy fluids.
 17. The system of claim 9 wherein the cleaning deviceincludes a material capable of selectively removing at least a portionof the urea from the fluids and optionally, a sorbent materialcomprising at least one of carbon and activated charcoal.
 18. A systemfor providing peritoneal dialysis to a patient, the system comprising: acatheter having an inflow lumen and an outflow lumen in communicationwith the patient's peritoneal cavity; a fluid circuit in fluidcommunication with the catheter thereby defining a closed fluid pathcapable of circulating fluid into, through and out of the peritonealcavity; a supply of dialysate coupled to the fluid circuit; a cyclerthat pumps the dialysate into the fluid circuit and circulates thedialysate during a treatment period along the closed fluid path toremove a therapeutically effective amount of solutes and ultrafiltratefrom the patient; a supply of an osmotic fluid coupled to the fluidcircuit downstream from and separately from the supply of dialysate andcoupled nearer to the patient than the supply of dialysate; a cleaningdevice coupled to the fluid circuit, the cleaning device capable ofremoving an amount of the solutes from the dialysate including at leasta portion of urea; and a discharge path coupled to the fluid circuit fordraining fluid from the fluid circuit.
 19. The system of claim 18wherein the system is capable of obtaining a clearance level includingabout 2.1 to about 2.6 for urea.
 20. The system of claim 18 wherein theclearance level further includes about 72 l/wk to about 90 l/wk forcreatinine.
 21. The system of claim 18 wherein the clearance levelfurther includes about 3.5 g/wk for phosphate.
 22. The system of claim18 wherein the clearance level further includes about 600 mg/wk for β2microglobulin.
 23. The system of claim 18, further comprising areservoir fluidly coupled to the fluid circuit via the cycler and one ormore pumps and branching off the closed loop for moving fluid at acontrolled flowrate from the fluid circuit to the reservoir and from thereservoir to the fluid circuit, and wherein the reservoir is adapted toprovide a variable increase in volume capacity to the fluid circuitallowing the system to compensate for an increase in fluid volume in thefluid circuit during treatment.